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U.S. Department of Health and Human Services

Class 2 Device Recall EDDP Strip

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  Class 2 Device Recall EDDP Strip see related information
Date Initiated by Firm March 04, 2014
Date Posted April 07, 2014
Recall Status1 Terminated 3 on May 09, 2014
Recall Number Z-1376-2014
Recall Event ID 67665
Product EDDP Strip;

Santa Clara, CA 95054
Code Information Catalog number: 74021, All lots
Recalling Firm/
LumiQuick Diagnostics Inc.
2946 Scott Blvd
Santa Clara CA 95054-3312
For Additional Information Contact Doug Rundle
Manufacturer Reason
for Recall
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
FDA Determined
Cause 2
No Marketing Application
Action Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
Quantity in Commerce ALL
Distribution Distributed in the states of CA, FL, NJ, TX, and NY.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.